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LAU-7b for COVID-19 (RESOLUTION Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Laurent Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes, pre-existing cardiovascular disease, pre-existing respiratory disease, active or former smoker with a 20 pack-years of smoking history, obesity as depicted by body mass index ≥ 30, laboratory tests indicative of a higher risk of COVID-19-related complications, patient aged 70 years and older at higher risk, documented positive test for the SARS-CoV-2 virus, under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for COVID-19 disease, health status must be 3 or 4 on the ordinal scale, and not previously a '5 or a 6', if female, must meet specific criteria for birth control, ability to understand and give informed consent, deemed capable of adequate compliance, and able to swallow the study drug capsules
Subjects must exhibit symptoms of COVID-19 disease at screening and/or since the start of their hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on days 1, 14, 29, 45 and 60
Awards & highlights

RESOLUTION Trial Summary

This trial is testing a new drug to see if it can help people with COVID-19 who are hospitalized and at risk for complications.

Who is the study for?
Adults hospitalized with COVID-19 who are at higher risk due to factors like diabetes, heart or lung disease, obesity, a history of smoking, being aged 70+, or specific lab results. Must not be critically ill (not expected in ICU within 24h), pregnant/breastfeeding, have severe liver/kidney issues, certain allergies/sensitivities, or be on another drug trial recently.Check my eligibility
What is being tested?
The study is testing LAU-7b's effectiveness against COVID-19 compared to a placebo. Hospitalized adults at high risk for complications will randomly receive either the actual medication or a dummy pill without knowing which one they're getting.See study design
What are the potential side effects?
While the side effects of LAU-7b aren't detailed here, typical clinical trial concerns may include allergic reactions to components in the capsule and potential unknown risks since it's under investigation.

RESOLUTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have specific health conditions or risk factors including diabetes, heart or lung disease, history of smoking, obesity, positive COVID-19 test, or being in a hospital for COVID-19 treatment. You must be able to understand and consent to the study, and be able to take the study drug by swallowing capsules.
Select...
You must have symptoms of COVID-19 when you get screened or since you were admitted to the hospital.

RESOLUTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on days 1, 14, 29, 45 and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and on days 1, 14, 29, 45 and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of patients requiring mechanical ventilation and/or deceased (all causes) by Day 60 (Ordinal scale scores 6-7 inclusively)
Secondary outcome measures
Duration of hospitalization (days) within the study period Days 1-60, compared to placebo
Health status of the patient on the 7-point Ordinal Scale compared to placebo
Mean change from baseline of the ordinal scale patient health status as a function of assessment time, compared to placebo
+11 more

RESOLUTION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LAU-7bExperimental Treatment1 Intervention
Active drug as LAU-7b capsules
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral capsule (as inactive capsules identical to active arm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LAU-7b
2018
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Laurent Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
370 Total Patients Enrolled
Jean-Marie Houle, PhDStudy DirectorLaurent Pharmaceuticals Inc.
1 Previous Clinical Trials
204 Total Patients Enrolled

Media Library

LAU-7b (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04417257 — Phase 2 & 3
COVID-19 Research Study Groups: LAU-7b, Placebo
COVID-19 Clinical Trial 2023: LAU-7b Highlights & Side Effects. Trial Name: NCT04417257 — Phase 2 & 3
LAU-7b (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417257 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there previous examples of LAU-7b being tested in a clinical setting?

"LAU-7b was first investigated in 2020 by the Wake Forest University Health Science team. As of now, 187 trials have been completed while 2 are still recruiting participants. The majority of these studies are being conducted in Salt Lake City, Utah."

Answered by AI

Does this research have a global reach?

"University of Utah Health, NorthShore University Health System - Glenbrook Hospital, and University Medical Center are a few of the hospitals participating in this trial. There are also 24 other sites located throughout the country."

Answered by AI

Why did researchers design this clinical study in this way?

"The purpose of this clinical trial is to compare the outcomes of patients receiving a new medication to those receiving a placebo. The primary outcome measure is the proportion of patients requiring mechanical ventilation or who have died by Day 60. Secondary outcome measures include the rate of disease-related transfer to mechanical ventilation, time to mechanical ventilation, and mean change in health status as measured by the World Health Organization 7-point ordinal scale."

Answered by AI

Is this research unprecedented in the medical field?

"As of now, there are 2 ongoing clinical trials for LAU-7b in 28 different cities spread across 2 countries. The first trial was conducted in 2020 and was completed in Phase 2 & 3. It was sponsored by Laurent Pharmaceuticals Inc. and had 508 participants. In the years since 2020, an additional 187 trials have been carried out."

Answered by AI
~26 spots leftby Mar 2025